ITI Using SCT800 Combining Daratumumab or SCT800 Alone in Hemophilia A Adolescents and Adults With High Titer Inhibitor

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the time of response, sustained remission rate, and relapse rate of CD38 monoclonal antibody (Daratumumab) combined with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer inhibitors.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Collaborator: Sinocelltech Ltd.
• Treatments: Daratumumab

Criteria

Inclusion Criteria

1. Moderate or severe hemophilia A;

2. Aged 14-66 years old;

3. Inhibitor positive at 2 consecutive visits;

4. Inhibitor titer > 10 BU at the screening visit.

Exclusion Criteria:

1. The patient has contraindications to drug ingredients or hamster protein allergy;

2. Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s);

3. Failed systemic ITI treatment in history;

4. Poor patients compliance;

5. The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.